MAUDE Adverse Event Report: TRIVIDIA HEALTH INC PEN NEEDLES FG; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	PNDL, 3BV TVH TP 31G 5MMTC 100CT 30/CS GREEN
Medical Device Problem Codes	Component Missing (2306); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned - product evaluation in-process.Most likely underlying root cause is pending investigation completion.Note: customer contacted manufacturer in follow-up call on 22-jun-2021 and stated the replacement pen needles received from the pharmacy had resolved the initial concern.
Event or Problem Description
Consumer reported complaint for the 31g trueplus pen needles.The customer stated when she went to use one of the pen needles, it did not aspirate/dispense her insulin.The customer stated that the part of the pen needle was missing; customer had stated the front part of the needle was there, but the back part that connects to her novolog flex pen was not there.Customer has been using the product out of this package for a few weeks.The package had not been open or damaged when received by the customer.The customer is using compatible product and the pen needle was aligned properly.At the time of the call the customer felt well and did not report any symptoms.The customer did not claim to be injured while using the pen needles and no medical intervention related to the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 04-aug-2021: h3: was the device evaluated by the manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: pen needles were returned for evaluation.Pen needles were visually inspected and no defect found.Returned product was forwarded to supplier quality to contact manufacturer.Manufacturer investigation completed and no abnormalities observed.Most likely underlying root cause: mlc-009: use error caused or contributed to event.

• Brand Name: PEN NEEDLES FG
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 12107474
• Report Number: 1000113657-2021-00412
• Device Sequence Number: 12044116
• Product Code: FMI
• UDI-Device Identifier: 00021292012786
• UDI-Public: (01)00021292012786
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2025
• Device Model Number: PNDL, 3BV TVH TP 31G 5MMTC 100CT 30/CS GREEN
• Device Catalogue Number: S5H01B31-100TC
• Device Lot Number: 0C601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Distributor Facility Aware Date: 06/07/2021
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1